| Device Classification Name |
Brush, Dermabrasion, Powered
|
| 510(k) Number |
K905046 |
| Device Name |
DERMABRADER |
| Applicant |
| Aaron Medical Industries |
| 1640 Central Ave. |
|
St. Petersburg,
FL
33712
|
|
| Applicant Contact |
ROBERT SARON |
| Correspondent |
| Aaron Medical Industries |
| 1640 Central Ave. |
|
St. Petersburg,
FL
33712
|
|
| Correspondent Contact |
ROBERT SARON |
| Regulation Number | 878.4820 |
| Classification Product Code |
|
| Date Received | 11/08/1990 |
| Decision Date | 12/19/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|